Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT01118559
Status:
COMPLETED
Last Update Posted:
2010-05-06
First Post:
2010-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-05', 'studyFirstSubmitDate': '2010-05-05', 'studyFirstSubmitQcDate': '2010-05-05', 'lastUpdatePostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of YM150 and its metabolites', 'timeFrame': 'for 3 days after drug administration'}], 'secondaryOutcomes': [{'measure': 'Safety assessed by AEs, vital signs, 12-lead ECG and lab tests', 'timeFrame': 'for 3 days after drug administration'}, {'measure': 'PT (prothrombin time)', 'timeFrame': 'for 3 days after drug administration'}, {'measure': 'aPTT (activated partial thromboplastin time)', 'timeFrame': 'for 2 days after drug administration'}, {'measure': 'FXa (factor Xa) activity', 'timeFrame': 'for 1 days after drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YM150', 'Food effect', 'Healthy volunteer'], 'conditions': ['Healthy', 'Pharmacokinetics of YM150']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.', 'detailedDescription': 'To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight: ≥50.0 kg, \\<80.0 kg\n* BMI: ≥17.6, \\<26.4\n* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests\n\nExclusion Criteria:\n\n* Received any investigational drugs within 120 days before the study\n* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study\n* Received medication within 7 days before the study\n* A deviation from the assessment criteria of physical examinations or laboratory tests\n* A deviation from the normal reference range of coagulation test \\[PT or aPTT\\]\n* History of drug allergies\n* Upper gastrointestinal disease within 7 days before the study\n* Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases\n* Concurrent or previous malignant tumor\n* Previous treatment with YM150'}, 'identificationModule': {'nctId': 'NCT01118559', 'briefTitle': 'A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150', 'orgStudyIdInfo': {'id': '150-CL-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fast-fed sequence group', 'description': 'drug is administered in a fasted condition first, and fed-condition study follows', 'interventionNames': ['Drug: YM150']}, {'type': 'EXPERIMENTAL', 'label': 'fed-fast sequence group', 'description': 'drug is administered in a fed condition first, and fasted-condition study follows', 'interventionNames': ['Drug: YM150']}], 'interventions': [{'name': 'YM150', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['fast-fed sequence group', 'fed-fast sequence group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyushu', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director', 'oldOrganization': 'Astellas Pharma, Inc'}}}}